QP Certification Not applicable to study Clause Samples

This clause establishes that Qualified Person (QP) certification requirements do not apply to the study in question. In practice, this means that the study's investigational products or processes are exempt from the standard QP review and certification typically mandated for clinical trials or pharmaceutical manufacturing in certain jurisdictions. By clarifying this exemption, the clause ensures that parties understand QP oversight is not required, thereby streamlining regulatory compliance and avoiding unnecessary procedural delays.
QP Certification Not applicable to study. 16.1 The QP should be guided in fulfilling their duties by the Code of Practice for QPs in the Pharmaceutical Industry. NA 16.2 No product will be dispatched without prior approval by the CUSTOMER. 16.3 The sponsor is responsible for ensuring that all products, which they intend to release for distribution to clinical sites, have been certified by a QP. 16.4 The CUSTOMER is responsible for ensuring that the API is manufactured according to GMP. Where product is undergoing QP certification by CATALENT, the CUSTOMER must provide information requested by the Catalent QP as evidence of GMP compliance. 16.5 CUSTOMER is responsible for ensuring the required Ethics Committee and Regulatory approvals are in place before requesting shipment to a clinical site. 16.6 Responsibility for QP certification will be defined for each study in the project documentation. 16.7 Where CUSTOMER is responsible Tor QP certification of the finished product, the sponsor will provide a final release certificate for each batch of product, signed by an eligible QP, as evidence of QP certification prior to CATALENT Internal release and distribution of product to site by CATALENT. 16.8 For manufacture and packaging which takes place within the EU, unless otherwise specified in project documentation, a CATALENT QP will provide a certificate confirming that operations carried out at a CATALENT facility have been conducted in compliance with EU Good Manufacturing Practice (GMP). 16.9 If specified in Project documentation, a CATALENT QP will confirm that the product complies with the specification noted in the Clinical Trial Application (CTA) and other documents provided by the CUSTOMER. The CATALENT QP will require the CUSTOMER to provide that part of the CTA and other specifications pertinent to the activities carried out by Catalent. The CTA must be in the English language and the CUSTOMER must confirm that the content of any CTA submitted in another language is identical. 16.10 If the final certification is the responsibility of the CATALENT QP, CATALENT is named as the “Authorized site for release of the finished product or Investigational Medicinal Product (IMP) in the Community” as recorded in the CTA. To discharge these duties, the CATALENT QP will require CUSTOMER to provide the following: ● Clinical Trial Application and Investigational Medicinal Product Dossier (CTA and IMPD) or equivalent for each country (provided in the English language and confirmation that applications in othe...
View Source

Related to QP Certification Not applicable to study

  • Certification Regarding Lobbying Applicable to Grants Subgrants, Cooperative Agreements, and Contracts Exceeding $100,000 in Federal Funds Submission of this certification is a prerequisite for making or entering into this transaction and is imposed by section 1352, Title 31, U.S. Code. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. The undersigned certifies, to the best of his or her knowledge and belief, that: (1) No Federal appropriated funds have been paid or will be paid by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of congress, or an employee of a Member of Congress in connection with the awarding of a Federal contract, the making of a Federal grant, the making of a Federal loan, the entering into a cooperative agreement, and the extension, continuation, renewal, amendment, or modification of a Federal contract, grant, loan, or cooperative agreement.

  • OFAC Certification Company certifies that (i) it is not acting on behalf of any person, group, entity, or nation named by any Executive Order or the United States Treasury Department, through its Office of Foreign Assets Control (“OFAC”) or otherwise, as a terrorist, “Specially Designated Nation”, “Blocked Person”, or other banned or blocked person, entity, nation, or transaction pursuant to any law, order, rule or regulation that is enforced or administered by OFAC or another department of the United States government, and (ii) Company is not engaged in this transaction on behalf of, or instigating or facilitating this transaction on behalf of, any such person, group, entity or nation.

  • AS9100 Certification ‌ AS9100 Certification, specifies requirements for a quality management system to demonstrate the Contractor’s ability to consistently meet the customer requirements as well as statutory and regulatory requirements for the aerospace industry. An AS9100 Certification, is not mandatory; however, Contractors who desire to compete for work within the aerospace industry are encouraged to have AS9100 Certification, during the entire term of OASIS. The Contractor shall notify the OASIS CO, in writing, if there are any changes in the status of their AS9100 Certification, and provide the reasons for the change and copies of audits from an AS9100 Certification Body, as applicable. If only part of a Contractor’s organization is AS9100, certified, the Contractor shall make the distinction between which business units or sites and geographic locations have been certified.

  • Annual Reports on Assessment of Compliance with Servicing Criteria (a) On or before March 1 of each year commencing in March 2018, the Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian, the Operating Advisor and, if it has made (or is required to make) an Advance during the applicable calendar year, the Trustee, each at its own expense, shall furnish (and each of the preceding parties, as applicable, (i) with respect to any Servicing Function Participant of such party that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Servicing Function Participant to furnish, and (ii) with respect to any other Servicing Function Participant of such party (other than any party to this Agreement), shall cause such Servicing Function Participant to furnish) (each Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian, the Operating Advisor, any Servicing Function Participant and, if it has made (or is required to make) an Advance during the applicable calendar year, the Trustee, as the case may be, a “Reporting Servicer”) to the Certificate Administrator, the Trustee, the Serviced Companion Loan Holders (or, in the case of a Serviced Companion Loan that is part of an Other Securitization Trust, the applicable Other Depositor and Other Exchange Act Reporting Party), the Operating Advisor (only in the case of a report furnished by the Special Servicer) and the Depositor, a report on an assessment of compliance with the Relevant Servicing Criteria (together with a copy thereof in ▇▇▇▇▇-Compatible Format, or in such other format as otherwise agreed upon by the Depositor, the Certificate Administrator, the applicable Other Depositor, the applicable Other Exchange Act Reporting Party and the applicable Certifying Servicer) that complies in all material respects with the requirements of Item 1122 of Regulation AB and contains (A) a statement by such Reporting Servicer of its responsibility for assessing compliance with the Relevant Servicing Criteria, (B) a statement that such Reporting Servicer used the Servicing Criteria to assess compliance with the Relevant Servicing Criteria, (C) such Reporting Servicer’s assessment of compliance with the Relevant Servicing Criteria as of the end of and for the preceding calendar year, including, if there has been any material instance of noncompliance with the Relevant Servicing Criteria, a discussion of each such failure and the nature and status thereof and (D) a statement that a registered public accounting firm has issued an attestation report on such Reporting Servicer’s assessment of compliance with the Relevant Servicing Criteria as of and for such period. Copies of all compliance reports delivered pursuant to this Section 10.09 shall be provided to any Certificateholder, upon the written request thereof, by the Certificate Administrator. Each such report shall be addressed to the Depositor and each Other Depositor (if addressed) and signed by an authorized officer of the applicable company, and shall address each of the Relevant Servicing Criteria specified on a certification substantially in the form of Exhibit O to this Agreement delivered to the Depositor on the Closing Date. Promptly after receipt of each such report, (i) the Depositor and each Other Depositor may review each such report and, if applicable, consult with the each Reporting Servicer as to the nature of any material instance of noncompliance with the Relevant Servicing Criteria, and (ii) the Certificate Administrator shall confirm that the assessments, taken individually address the Relevant Servicing Criteria for each party as set forth on Exhibit O to this Agreement and notify the Depositor of any exceptions. For the avoidance of doubt, the Trustee shall have no obligation or duty to determine whether any such report (other than any such report furnished by the Trustee or any Servicing Function Participant of the Trustee) is in form and substance in compliance with the requirements of Regulation AB. (b) On the Closing Date, the Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian, the Trustee and the Operating Advisor each acknowledge and agree that Exhibit O to this Agreement sets forth the Relevant Servicing Criteria for such party. (c) No later than the end of each fiscal year for the Trust, the Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian, the Operating Advisor and, if it has made (or is required to make) an Advance during such fiscal year, the Trustee shall notify the Certificate Administrator, the Depositor, each Other Exchange Act Reporting Party and each Other Depositor as to the name of each Servicing Function Participant utilized by it, and the Certificate Administrator shall notify the Depositor and each Other Depositor as to the name of each Servicing Function Participant utilized by it, during such fiscal year, and each such notice will specify what specific Servicing Criteria will be addressed in the report on assessment of compliance prepared by such Servicing Function Participant. When the Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian, the Trustee (if applicable), the Operating Advisor and any Servicing Function Participant submit their assessments pursuant to Section 10.09(a) of this Agreement, such parties will also at such time include the assessment (and related attestation pursuant to Section 10.10 of this Agreement) of each Servicing Function Participant engaged by it. The fiscal year for the Trust shall be January 1 through and including December 31 of each calendar year. (d) In the event the Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian, the Trustee (if it has made, or is required to make, an Advance during the applicable period) or the Operating Advisor is terminated or resigns pursuant to the terms of this Agreement, such party shall provide, and each such party shall cause (or, if the Servicing Function Participant is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause) any Servicing Function Participant of such party to provide (and the Master Servicer, the Special Servicer and the Certificate Administrator shall, with respect to any Servicing Function Participant that resigns or is terminated under any applicable servicing agreement, cause such Servicing Function Participant (or, in the case of each Servicing Function Participant that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Servicing Function Participant) to provide) an annual assessment of compliance pursuant to this Section 10.09, coupled with an attestation as required in Section 10.10 of this Agreement with respect to the period of time that the Master Servicer, the Special Servicer, the Certificate Administrator, the Custodian, the Trustee (if it has made, or is required to make, an Advance during such period of time) or the Operating Advisor was subject to this Agreement or the period of time that the applicable Servicing Function Participant was subject to such other servicing agreement. With respect to each Outside Serviced Mortgage Loan serviced under the applicable Outside Servicing Agreement, the Certificate Administrator shall use commercially reasonable efforts to obtain, and upon receipt deliver to the Depositor, an annual report on assessment of compliance as described in this Section and an attestation as described in Section 10.10 from the related Outside Servicer, Outside Special Servicer, Outside Custodian, Outside Trustee and Outside Paying Agent or Outside Certificate Administrator and in form and substance similar to the annual report on assessment of compliance described in this Section 10.09 and the attestation described in Section 10.10.

  • Additional Certifications Any certificate signed by any director or officer of the Corporation and delivered to an Agent or to counsel for such Agent in connection with an offering of Notes or the sale of Notes to an Agent as principal shall be deemed a representation and warranty by the Corporation to such Agent as to the matters covered thereby on the date of such certificate and at each Representation Date subsequent thereto.